BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3213071 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09807
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED ASYMPTOMATIC THERAPY FROM THE DEVICE. UPON INTERROGATION, THE PACE/SENSE EGM AND SHOCK EGM APPEARED TO BE SIMILAR TO THE PATIENT CURRENT RHYTHM OF SINUS TACHYCARDIA. THE EVENT WAS DETECTED IN THE VENTRICULAR TACHYCARDIA ZONE AND WAS INITIALLY INHIBITED WITH RHYTHM ID UNTIL THE SUSTAINED RATE DURATION TIMER EXPIRED. THE DEVICE THEN DELIVERED INAPPROPRIATE ANTI TACHYCARDIA THERAPY AND INAPPROPRIATE SHOCK WHICH DID NOT EFFECT THE RHYTHM. THE EVENT ENDED AFTER THERAPY WAS EXHAUSTED. THE PATIENTS SINUS TACHYCARDIA GRADUALLY SLOWED DOWN. THE DEVICE WAS REPROGRAMMED WITH THE SUSTAINED RATE DURATION TIMED BEING TURNED OFF IN THE VT ZONE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314200 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1